CN109432013B - Florfenicol soluble powder and preparation method thereof - Google Patents
Florfenicol soluble powder and preparation method thereof Download PDFInfo
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Abstract
The invention relates to the technical field of veterinary medicines, and particularly relates to florfenicol soluble powder which comprises the following components in parts by weight: 10 parts of florfenicol, 30-36 parts of coating agent, 0.4-2 parts of cosolvent and 4-10 parts of diluent. The invention also relates to a preparation method of the florfenicol soluble powder. The florfenicol powder has solubility up to 657.8mg/ml and better solubility.
Description
Technical Field
The invention relates to the technical field of veterinary drugs, and particularly relates to florfenicol soluble powder and a preparation method thereof.
Background
Florfenicol is a common veterinary antibiotic at present, has wide antibacterial spectrum, strong antibacterial action and low minimum antibacterial concentration, and has the antibacterial effect 15-20 times that of chloramphenicol and thiamphenicol. The medicine concentration in the tissues can reach the peak value 60 minutes after administration, the disease condition can be controlled rapidly, the safety is high, no toxicity exists, no residue exists, potential hazards of aplastic anemia exist, and the medicine is suitable for large-scale farms. The medicine is easy to absorb, widely distributed in vivo, is a quick-acting and long-acting preparation, has no potential hidden trouble of aplastic anemia, and has good safety. In addition, the price is moderate, and the medicine is cheaper than other medicines for preventing and treating respiratory diseases, and the medicine cost is easy to be accepted by users. Because of the characteristics, the domestic florfenicol is widely applied and becomes the first choice medicament for preventing and treating the bacterial infection diseases of the respiratory tract and the digestive tract of the livestock. However, the medicine has poor water solubility, and the bioavailability is greatly reduced by mixing and administrating. Thus, increasing the solubility of florfenicol in water will increase the effectiveness of florfenicol in treating disease in poultry. The florfenicol water-soluble technology in the market at present mainly comprises a saturated solution method, an ultrasonic method, a cosolvent method and the like, for example, the florfenicol quick-release type water-soluble powder preparation including cyclodextrin and a preparation method thereof (CN 102160854; published: 20110824) comprise the following process steps: the florfenicol, the cyclodextrin and the water are heated to 80 ℃ and stirred for 1h, and then are dried at 105 ℃ and screened for dilution. The powder prepared by the process has low solubility, and the drying step in industrial mass production has long time and high cost; "A method for preparing florfenicol soluble powder (CN 106798731; published Japanese: 20170606)" comprises the following steps: dissolving florfenicol with dimethylacetamide and ethanol, dissolving cyclodextrin with urea and vitamin C by adding water, mixing the two solutions, stirring for 9h, centrifuging, and spray-drying the supernatant. The preparation process has the disadvantages of high cost of added auxiliary agents, complex process steps, waste of solid after centrifugation and the like.
Disclosure of Invention
The invention aims to: aiming at the defects in the prior art, the florfenicol soluble powder with better solubility is provided.
Another object of the invention is: aiming at the defects in the prior art, the florfenicol soluble preparation method is simple in process and convenient to operate, and the solubility of florfenicol powder is greatly improved.
In order to solve the first technical problem, the technical scheme of the invention is as follows:
the florfenicol soluble powder comprises the following components in parts by weight: 10 parts of florfenicol, 30-36 parts of coating agent, 0.4-2 parts of cosolvent and 4-10 parts of diluent.
As an improved technical scheme, the coating agent is one or a mixture of two or more of hydroxypropyl-beta-cyclodextrin, alpha-cyclodextrin, beta-cyclodextrin and gamma-cyclodextrin.
As a preferred technical scheme, the coating agent is beta-cyclodextrin.
As an improved technical scheme, the cosolvent is hydroxypropyl methyl cellulose, PVP-K30 and carboxymethyl cellulose.
As a preferable technical scheme, the cosolvent is hydroxypropyl methyl cellulose.
As an improved technical scheme, the diluent is glucose, lactose, fructose, soluble starch and mannitol.
As a preferred technical scheme, the diluent is glucose.
In order to solve the second technical problem, the technical scheme of the invention is as follows:
a preparation method of florfenicol soluble powder comprises the following steps:
(1) weighing the coating agent according to the parts by weight, adding purified water, heating to 80 ℃, and stirring and mixing to obtain a clear solution;
(2) weighing florfenicol and a cosolvent according to parts by weight, sequentially adding the florfenicol and the cosolvent into the clear solution obtained in the step (1), stirring and mixing, and keeping the temperature for 1-8 hours to obtain a mixed solution;
(3) carrying out spray drying on the mixed solution obtained in the step (2) to obtain florfenicol-containing dry powder;
(4) and (4) uniformly mixing the dry powder obtained in the step (3) with the diluent weighed according to the weight part, so as to obtain the florfenicol soluble powder.
By adopting the technical scheme, compared with the prior art, the invention has the following advantages:
the florfenicol soluble powder contains a coating agent and a cosolvent, the solubility of the florfenicol in water is greatly improved by the matching use of the coating agent and the cosolvent, wherein when the coating agent is beta-cyclodextrin, the cosolvent is hydroxypropyl methyl cellulose, and ether bonds in the hydroxypropyl methyl cellulose are hydrophilic and can be combined with hydrogen bonds in water, so that the activity of the water is greatly improved, and the solubility and the clarity of the florfenicol in the water are further improved.
(2) When the florfenicol soluble powder is prepared, the coating agent is dissolved at 80 ℃, then the florfenicol powder and the cosolvent are sequentially added, stirred and mixed, the temperature is kept for 1-8h, the temperature keeping time is controlled within 1-8h, and particularly, the solubility of the florfenicol soluble powder in water can be greatly improved when the temperature keeping time is controlled to be 8 h.
Detailed Description
The present invention will be described in further detail in order to make the objects, technical solutions and advantages of the present invention more apparent. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.
Example 1
The florfenicol soluble powder comprises the following components in parts by weight: 10 parts of florfenicol, 30 parts of a coating agent, 0.4 part of a cosolvent and 10 parts of a diluent.
The preparation method comprises the following steps:
(1) weighing a coating agent (hydroxypropyl-beta-cyclodextrin) according to parts by weight, adding 220g of purified water, heating to 80 ℃, and stirring and mixing to obtain a clear solution;
(2) weighing florfenicol and a cosolvent (hydroxypropyl methyl cellulose) according to parts by weight, sequentially adding the florfenicol and the cosolvent into the clear solution obtained in the step (1), stirring and mixing, and preserving heat for 4 hours to obtain a mixed solution;
(3) carrying out spray drying (the air inlet temperature is 180 ℃, the air outlet temperature is 75 ℃) on the mixed solution obtained in the step (2) to obtain dry powder containing florfenicol;
(4) and (4) uniformly mixing the dry powder obtained in the step (3) with a diluent (fructose) weighed according to the weight part, so as to obtain the florfenicol 19.8% soluble powder.
Example 2
The florfenicol soluble powder comprises the following components in parts by weight: 10 parts of florfenicol, 31 parts of a coating agent, 0.6 part of a cosolvent and 9 parts of a diluent.
The preparation method comprises the following steps:
(1) weighing coating agents (alpha-cyclodextrin and gamma-cyclodextrin) according to parts by weight, adding 230g of purified water, heating to 80 ℃, and stirring and mixing to obtain a clear solution;
(2) weighing florfenicol and a cosolvent (hydroxypropyl methyl cellulose) according to parts by weight, sequentially adding the florfenicol and the cosolvent into the clear solution obtained in the step (1), stirring and mixing, and preserving heat for 4 hours to obtain a mixed solution;
(3) carrying out spray drying (the air inlet temperature is 185 ℃ and the air outlet temperature is 78 ℃) on the mixed solution obtained in the step (2) to obtain florfenicol-containing dry powder;
(4) and (4) uniformly mixing the dry powder obtained in the step (3) with a diluent (fructose) weighed according to the weight part, so as to obtain the florfenicol 19.7% soluble powder.
Example 3
The florfenicol soluble powder comprises the following components in parts by weight: 10 parts of florfenicol, 32 parts of a coating agent, 0.8 part of a cosolvent and 8 parts of a diluent.
The preparation method comprises the following steps:
(1) weighing the coating agent (beta-cyclodextrin) according to parts by weight, adding 240g of purified water, heating to 80 ℃, and stirring and mixing to obtain a clear solution;
(2) weighing florfenicol and a cosolvent (hydroxypropyl methyl cellulose) according to parts by weight, sequentially adding the florfenicol and the cosolvent into the clear solution obtained in the step (1), stirring and mixing, and preserving heat for 4 hours to obtain a mixed solution;
(3) carrying out spray drying (the air inlet temperature is 190 ℃ and the air outlet temperature is 80 ℃) on the mixed solution obtained in the step (2) to obtain florfenicol-containing dry powder;
(4) and (4) uniformly mixing the dry powder obtained in the step (3) with a diluent (fructose) weighed according to the weight part, so as to obtain the florfenicol 19.6% soluble powder.
Example 4
The florfenicol soluble powder comprises the following components in parts by weight: 10 parts of florfenicol, 33 parts of a coating agent, 0.6 part of a cosolvent and 7 parts of a diluent.
The preparation method comprises the following steps:
(1) weighing the coating agent (beta-cyclodextrin) according to the weight parts, adding 250g of purified water, heating to 80 ℃, and stirring and mixing to obtain a clear solution;
(2) weighing florfenicol and a cosolvent (hydroxypropyl methyl cellulose) according to parts by weight, sequentially adding the florfenicol and the cosolvent into the clear solution obtained in the step (1), stirring and mixing, and keeping the temperature for 8 hours to obtain a mixed solution;
(3) carrying out spray drying (the air inlet temperature is 192 ℃, the air outlet temperature is 82 ℃) on the mixed solution obtained in the step (2) to obtain dry powder containing florfenicol;
(4) and (4) uniformly mixing the dry powder obtained in the step (3) with a diluent (glucose) weighed according to the weight part, so as to obtain the florfenicol 19.7% soluble powder.
Example 5
The florfenicol soluble powder comprises the following components in parts by weight: 10 parts of florfenicol, 34 parts of a coating agent, 1.3 parts of a cosolvent and 6 parts of a diluent.
The preparation method comprises the following steps:
(1) weighing the coating agent (beta-cyclodextrin) according to parts by weight, adding 255g of purified water, heating to 80 ℃, and stirring and mixing to obtain a clear solution;
(2) weighing florfenicol and a cosolvent (PVP-K30) according to parts by weight, sequentially adding the florfenicol and the cosolvent into the clarified solution obtained in the step (1), stirring and mixing, and preserving heat for 8 hours to obtain a mixed solution;
(3) carrying out spray drying (inlet air temperature is 195 ℃ and outlet air temperature is 85 ℃) on the mixed solution obtained in the step (2) to obtain dry powder containing florfenicol;
(4) and (3) uniformly mixing the dry powder obtained in the step (3) with a diluent (soluble starch) weighed according to the weight part, so as to obtain the florfenicol 19.5% soluble powder.
Example 6
The florfenicol soluble powder comprises the following components in parts by weight: 10 parts of florfenicol, 35 parts of a coating agent, 1.6 parts of a cosolvent and 5 parts of a diluent.
The preparation method comprises the following steps:
(1) weighing the coating agent (beta-cyclodextrin) according to parts by weight, adding 260g of purified water, heating to 80 ℃, and stirring and mixing to obtain a clear solution;
(2) weighing florfenicol and a cosolvent (carboxymethyl cellulose) according to parts by weight, sequentially adding the florfenicol and the cosolvent into the clear solution obtained in the step (1), stirring and mixing, and keeping the temperature for 8 hours to obtain a mixed solution;
(3) carrying out spray drying (the air inlet temperature is 198 ℃ and the air outlet temperature is 88 ℃) on the mixed solution obtained in the step (2) to obtain dry powder containing florfenicol;
(4) and (3) uniformly mixing the dry powder obtained in the step (3) with a diluent (mannitol) weighed according to the weight part, so as to obtain the florfenicol 19.4% soluble powder.
Example 7
The florfenicol soluble powder comprises the following components in parts by weight: 10 parts of florfenicol, 36 parts of a coating agent, 1.8 parts of a cosolvent and 4 parts of a diluent.
The preparation method comprises the following steps:
(1) weighing the coating agent (beta-cyclodextrin) according to parts by weight, adding 270g of purified water, heating to 80 ℃, and stirring and mixing to obtain a clear solution;
(2) weighing florfenicol and a cosolvent (hydroxypropyl methyl cellulose) according to parts by weight, sequentially adding the florfenicol and the cosolvent into the clear solution obtained in the step (1), stirring and mixing, and preserving heat for 5 hours to obtain a mixed solution;
(3) carrying out spray drying (air inlet temperature is 200 ℃, air outlet temperature is 90 ℃) on the mixed solution obtained in the step (2) to obtain florfenicol-containing dry powder;
(4) and (4) uniformly mixing the dry powder obtained in the step (3) with a diluent (glucose) weighed according to the weight part, so as to obtain the florfenicol 19.3% soluble powder.
In order to better demonstrate the better solubility of the florfenicol soluble powder of the present invention, two comparative examples are given below.
Comparative example 1
Different from the example 4, the florfenicol soluble powder does not contain a cosolvent, and the rest operations are the same;
comparative example 2
Is commercially available water-soluble florfenicol.
Comparative example 3
Is commercially available water-soluble florfenicol.
The florfenicol solutions of examples 1-7 and comparative examples 1-3 were subjected to solubility determination, and the results of the determination are shown in table 1.
TABLE 1
Observing the data in table 1, it was found that the florfenicol soluble powders of examples 1-7 were much more soluble in water than the florfenicol soluble powders of comparative examples 1, 2 and 3. The data of example 4, example 5, example 6 and example 7 show that the solubility of the florfenicol soluble powder in water can be greatly improved by using the coating agent (beta-cyclodextrin) and the cosolvent (hydroxypropyl methyl cellulose) in the florfenicol soluble powder, and the solubility of the florfenicol soluble powder can be greatly improved when the holding time is controlled to be 8 hours in the preparation process. Comparing example 4 with comparative example 1, it can be seen that the solubility increased 24-fold after the addition of co-solvent) over before, greatly increasing the solubility of florfenicol. Compared with the commercially available comparative example 1 and example 2, the solubility of the example 4 with the highest solubility is increased by 20.5 times and is far higher than that of the commercially available florfenicol soluble powder, so that the florfenicol soluble powder can be directly used for animal drinking water.
The florfenicol in example 4 and comparative examples 1-3 was subjected to dissolution measurement at a water temperature of 0-25 deg.c, and the measurement results are shown in table 2.
TABLE 2
As can be seen from the comparison of the dissolution conditions, the dissolution condition of example 4 is not influenced by the water temperature at all and can be used under any conditions.
The present patent is not limited to the above-mentioned embodiments, and those skilled in the art can make various changes without creative efforts from the above-mentioned conception, and fall within the protection scope of the present patent.
Claims (7)
1. The florfenicol soluble powder is characterized by comprising the following components in parts by weight: 10 parts of florfenicol, 30 parts of hydroxypropyl-beta-cyclodextrin, 0.4 part of hydroxypropyl methyl cellulose and 10 parts of fructose;
the preparation method comprises the following steps:
(1) weighing hydroxypropyl-beta-cyclodextrin according to parts by weight, adding 220g of purified water, heating to 80 ℃, and stirring and mixing to obtain a clear solution;
(2) weighing florfenicol and hydroxypropyl methyl cellulose according to parts by weight, sequentially adding the florfenicol and the hydroxypropyl methyl cellulose into the clear solution obtained in the step (1), stirring and mixing, and preserving heat for 4 hours to obtain a mixed solution;
(3) carrying out spray drying on the mixed solution obtained in the step (2), wherein the air inlet temperature is 180 ℃, and the air outlet temperature is 75 ℃, so as to obtain dry powder containing florfenicol;
(4) and (4) taking the dry powder in the step (3), and uniformly mixing the dry powder with the fructose weighed according to the weight part.
2. The florfenicol soluble powder comprises the following components in parts by weight: 10 parts of florfenicol, 32 parts of beta-cyclodextrin, 0.8 part of hydroxypropyl methyl cellulose and 8 parts of fructose;
the preparation method comprises the following steps:
(1) weighing beta-cyclodextrin according to parts by weight, adding 240g of purified water, heating to 80 ℃, and stirring and mixing to obtain a clear solution;
(2) weighing florfenicol and hydroxypropyl methyl cellulose according to parts by weight, sequentially adding the florfenicol and the hydroxypropyl methyl cellulose into the clear solution obtained in the step (1), stirring and mixing, and preserving heat for 4 hours to obtain a mixed solution;
(3) carrying out spray drying on the mixed solution obtained in the step (2), wherein the air inlet temperature is 190 ℃ and the air outlet temperature is 80 ℃ to obtain florfenicol-containing dry powder;
(4) and (4) taking the dry powder in the step (3), and uniformly mixing the dry powder with the fructose weighed according to the weight part.
3. The florfenicol soluble powder comprises the following components in parts by weight: 10 parts of florfenicol, 33 parts of beta-cyclodextrin, 0.6 part of hydroxypropyl methyl cellulose and 7 parts of glucose;
the preparation method comprises the following steps:
(1) weighing beta-cyclodextrin according to parts by weight, adding 250g of purified water, heating to 80 ℃, and stirring and mixing to obtain a clear solution;
(2) weighing florfenicol and hydroxypropyl methyl cellulose according to parts by weight, sequentially adding the florfenicol and the hydroxypropyl methyl cellulose into the clear solution obtained in the step (1), stirring and mixing, and keeping the temperature for 8 hours to obtain a mixed solution;
(3) carrying out spray drying on the mixed solution obtained in the step (2), wherein the air inlet temperature is 192 ℃, and the air outlet temperature is 82 ℃, so as to obtain dry powder containing florfenicol;
(4) and (4) taking the dry powder in the step (3), and uniformly mixing the dry powder with the glucose weighed according to the weight part.
4. The florfenicol soluble powder comprises the following components in parts by weight: 10 parts of florfenicol, 34 parts of beta-cyclodextrin, 301.3 parts of PVP-K and 6 parts of soluble starch;
the preparation method comprises the following steps:
(1) weighing beta-cyclodextrin according to parts by weight, adding 255g of purified water, heating to 80 ℃, and stirring and mixing to obtain a clear solution;
(2) weighing florfenicol and PVP-K30 according to parts by weight, sequentially adding the florfenicol and PVP-K30 into the clarified solution obtained in the step (1), stirring and mixing, and keeping the temperature for 8 hours to obtain a mixed solution;
(3) carrying out spray drying on the mixed solution obtained in the step (2), wherein the air inlet temperature is 195 ℃ and the air outlet temperature is 85 ℃ to obtain dry powder containing florfenicol;
(4) and (4) taking the dry powder in the step (3), and uniformly mixing the dry powder with the soluble starch weighed according to the weight part.
5. The florfenicol soluble powder comprises the following components in parts by weight: 10 parts of florfenicol, 35 parts of beta-cyclodextrin, 1.6 parts of carboxymethyl cellulose and 5 parts of mannitol;
the preparation method comprises the following steps:
(1) weighing beta-cyclodextrin according to parts by weight, adding 260g of purified water, heating to 80 ℃, and stirring and mixing to obtain a clear solution;
(2) weighing florfenicol and carboxymethyl cellulose according to parts by weight, sequentially adding the florfenicol and the carboxymethyl cellulose into the clarified solution obtained in the step (1), stirring and mixing, and keeping the temperature for 8 hours to obtain a mixed solution;
(3) carrying out spray drying on the mixed solution obtained in the step (2), wherein the air inlet temperature is 198 ℃, and the air outlet temperature is 88 ℃ to obtain florfenicol-containing dry powder;
(4) and (4) uniformly mixing the dry powder obtained in the step (3) with mannitol weighed according to the weight part, and obtaining the florfenicol 19.4% soluble powder.
6. The florfenicol soluble powder comprises the following components in parts by weight: 10 parts of florfenicol, 36 parts of beta-cyclodextrin, 1.8 parts of hydroxypropyl methyl cellulose and 4 parts of glucose;
the preparation method comprises the following steps:
(1) weighing beta-cyclodextrin according to parts by weight, adding 270g of purified water, heating to 80 ℃, and stirring and mixing to obtain a clear solution;
(2) weighing florfenicol and hydroxypropyl methyl cellulose according to parts by weight, sequentially adding the florfenicol and the hydroxypropyl methyl cellulose into the clear solution obtained in the step (1), stirring and mixing, and preserving heat for 5 hours to obtain a mixed solution;
(3) carrying out spray drying on the mixed solution obtained in the step (2), wherein the air inlet temperature is 200 ℃, and the air outlet temperature is 90 ℃, so as to obtain dry powder containing florfenicol;
(4) and (4) taking the dry powder in the step (3), and uniformly mixing the dry powder with the glucose weighed according to the weight part.
7. A process for the preparation of a florfenicol soluble powder of any one of claims 1-6.
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| CN112121016B (en) * | 2020-10-09 | 2022-11-22 | 清远海贝生物技术有限公司 | Water-soluble florfenicol powder and preparation method thereof |
| CN112190551A (en) * | 2020-11-20 | 2021-01-08 | 湖北龙翔药业科技股份有限公司 | Florfenicol soluble powder and preparation method thereof |
| CN112716902B (en) * | 2021-02-04 | 2021-10-12 | 广州市和生堂动物药业有限公司 | Florfenicol powder and preparation method thereof |
| CN115300461A (en) * | 2021-05-06 | 2022-11-08 | 江苏恒丰强生物技术有限公司 | Florfenicol soluble powder and preparation method thereof |
| CN114209656B (en) * | 2021-12-31 | 2023-08-01 | 浙江金朗博药业有限公司 | Florfenicol soluble powder and preparation method thereof |
| CN116036020A (en) * | 2022-08-31 | 2023-05-02 | 瑞普（天津）生物药业有限公司 | Florfenicol powder with high bioavailability and preparation method thereof |
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| CN104922073B (en) * | 2015-05-29 | 2016-05-04 | 广东腾骏动物药业股份有限公司 | A kind of solubility fluorobenzene Buddhist nun examines powder and preparation method thereof |
| CN105055319B (en) * | 2015-07-22 | 2018-04-10 | 浙江大飞龙动物保健品有限公司 | A kind of florfenicol soluble powder and preparation method thereof |
| CN106727334A (en) * | 2016-11-24 | 2017-05-31 | 山东滨州智源生物科技有限公司 | A kind of florfenicol water soluble pulvis and preparation method thereof |
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